GLYCOMAT HAEMOGLOBIN ANALYSER— 510(k) K920198

Name: FDA 510(k) clearance K920198
Creator: U.S. Food and Drug Administration
Published: 1992-07-21

Substantially Equivalent

Drew Scientific , Ltd.

FDA 510(k) clearance K920198 for GLYCOMAT HAEMOGLOBIN ANALYSER, Substantially Equivalent on 1992-07-21. Applicant: Drew Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Drew Scientific , Ltd.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1992-01-15
Decision date: 1992-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London W4 4ph Uk, GB

Download summary PDF View on FDA.gov ↗

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